Senior Director, Late-Stage Readiness Lead

Position Overview

• Location Type: [Not Specified]
• Employment Type: [Not Specified]
• Salary: [Not Specified]

Role Summary: We are seeking a Late-Stage Readiness Leader who will play a pivotal role in preparing Apogee’s Development functions for Phase 3 clinical studies, Biologics License Applications (BLAs), and supporting activities leading to regulatory approvals. Reporting to the SVP of Program and Portfolio Management, you will coordinate cross-functionally to prepare readiness plans and drive execution in collaboration with major stakeholders. This role requires a leader with extensive experience in late-stage clinical development, NDA or BLA submissions, and inspection-readiness planning.

About Apogee Therapeutics

Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company founded in 2022. It offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.

Key Responsibilities

• Conduct gap analysis and identify potential risks to trial or submission readiness, focusing on cross-functional dependencies, system/process availability, and resource planning.
• Drive cross-functional planning and preparation of Phase 3 or submission readiness by collaborating with Clinical Development, Biometrics, Clinical Operations, Regulatory, Quality Assurance, Supply Chain, Research & Translational Medicine, Commercial, and Program Management/Leadership teams.
• Regularly report on Phase 3 readiness progress to executive leadership, Program Team and other key stakeholders, including key milestones, risks, and overall strategy.
• Facilitate communication and support problem-solving and alignment between functions to ensure milestones and deliverables are met according to agreed timelines; track identified risks and create mitigation plans.
• Coordinate with functional leaders to ensure appropriate resources, funding, and timelines for Phase 3 trial preparation and BLA submission activities are in place.

Requirements

[Not Specified]

Application Instructions

[Not Specified]